Job Description

Description

This is a full time, onsite role at our Bethlehem, PA location.

ABEC is at the forefront of innovation in our industry, offering highly differentiated products and services driving exceptional growth. As we expand to meet increased demand and new opportunities, we seek talented individuals to join our team and support our continued success.

We’re in a significant growth phase, with multiple key roles open across our organization. If you’re qualified for multiple positions, we encourage you to apply to any that aligns with your skills and experience.

Company Overview:

ABEC is a leading supplier to the biopharmaceutical manufacturing industry. ABEC's unique value is based on combining long experience with the ability to engineer, design, manufacture, commission, qualify, and service the entire bioprocess to reduce overall cost, shorten time to market, and maximize productivity. ABEC's products include process and equipment engineering/consulting services, comprehensive site services, bioreactors and fermenters, filtration and chromatography systems, prep and hold systems, and cleaning/sterilization systems. 

Position Summary:
The Quality Engineer assists Quality Management with implementation of company-wide operations procedures and process to support the overall Quality Assurance plan.  This role supports Quality improvement throughout the shop floor and within the team concept and participate as cross-functional team member within assigned goal-oriented team responsibility.  
The Quality Engineer will analyze and provide defect data from various sources to the team in order to prioritize top issues to resolve and ensure zero defects. Drive root cause and problem-solving activities within the team. Support use of approved problem-solving tools. Develop defect detection criteria for teams to monitor during assembly. Track defects being worked during problem resolution and assures that all manufactured products meet customer specifications with the highest level of Quality possible, while achieving the company’s other performance objectives. 

Responsibilities:

 · Support and maintain ABEC Quality program. 

· Maintain and ensure compliance to ABEC SOP's.

· Support and maintain ABEC quality practices and guidelines. 

· Participate in internal and vendor audits as directed.

· Participate in FAT, IQ/OQ activities as assigned.

· Coordinate assigned CAPA activities (Root cause analysis, short- & long-term corrective and preventive actions).

· Coordinate assigned Continuous improvement initiatives.

· Review, approve and administer Engineering Change/Release Notices (ECN’s). 

· Complete Document Control and Change Management assignments as directed.

· Maintain documents in ABEC archives. 

· Support new product development activities as directed.

· Execute other tasks as assigned (Quality, Project, Product Development, etc.). 

· Follow all safety rules and policies. 

· Execute other tasks as assigned.

· Ability to travel when required. 

· Will play an active role in identifying and driving Continuous Improvement (CI) opportunity. 

Qualifications: 

• Bachelor’s Degree in Engineering required (Chemical, Mechanical or Electrical Engineering preferred).
• 3-5 years post graduate work in a quality field. 
• Experience with cGMP or ISO 9000, Six Sigma, CQE. 
• Candidates must possess strong interpersonal and problem-solving skills. 
• Excellent communication skills, both written and verbal.
• Detail oriented and ability to prioritize.
• Good at multitasking.
• Proficiency in Microsoft Office: specifically, Outlook, Word, and Excel.  
• Awareness of and prior experience with implementing Continuous Improvement (CI) a plus.   
• Prior Lean/Six Sigma experience a plus.